What is BS EN ISO 11137-2:2007?
BS EN ISO 11137-2 was developed to establish the right sterilisation dose for medical equipment. This international standard takes an in-depth look at the methods aligned with the two approaches in ISO 11137-1:2008, including dose setting to get a product specific dose; and dose substantiation to confirm a preselected dose of 25kG or 15kGy. These methods are based on a probability model that demonstrates the inactivation of microbial populations after radiation – such as gamma and ionising radiation – and involve performance tests of sterility on medical instruments.
How does it work?
BS EN ISO 11137-2 helps the user to choose and test their medical equipment for the verification of sterilisation doses. It also looks at the manner of sampling to ensure quality control, as well as microbiological testing. This standard includes various procedures for dose setting using bioburden information (Method 1), and dose setting using fraction positive information from incremental dosing (Method 2).
Who should buy it?
- Laboratories
- Manufacturers of medical equipment
- Quality assurers
- Persons responsible for sterilising medical equipment
- Regulatory bodies
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